Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01519466|
Recruitment Status : Completed
First Posted : January 27, 2012
Results First Posted : April 1, 2016
Last Update Posted : April 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Device: FreeStyle InsuLinx Device: FreeStyle Freedom Lite||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Subjects will use a FreeStyle InsuLinx blood glucose meter during the study
Device: FreeStyle InsuLinx
FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.
Device: FreeStyle Freedom Lite
FreeStyle Freedom Lite is a blood glucose meter
- Time in Target Blood Glucose Range [ Time Frame: Day 1-15 compared with Day 60-74 ]Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)
- HbA1c [ Time Frame: Day 1 compared with Day 74 ]
HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74).
The percentage of glycosylated hemoglobin in Diabetes Control and Complications Trial (DCCT) units was standardized to the newer International Federation of Clinical Chemistry (IFCC) units (mmol/mol).
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60. [ Time Frame: Day 60 compared to day 1 ]
The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (-3 to +3). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).
There is one question to assess the change in satisfaction with perceived frequency of Hypoglycaemia and one question to assess change satisfaction with perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less satisfied) to +3 (much more satisfied).
The 95% confidence intervals for the FreeStyle InsuLinx group DTSQc scores was calculated using a one-sample t-test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519466
|Diabetes Zentrum Mergentheim|
|Bad Mergentheim, Germany, 97980|
|Diabetes-Zentrum für Kinder und Jugendliche|
|Hannover, Germany, 30173|
|Institut für Diabetes - Technology Forschungs - und Entwicklungsgesellschaft mbH an der Universität Ulm|
|Ulm, Germany, D-89081|
|VU University Medical Centre (VUMC)|
|Amsterdam, Netherlands, 1007 MB|
|Principal Investigator:||Prof. Michaela Diamant||VU University Medical Centre (VUMC)|